Rugalin - ( Pregabalin Capsules IP 75mg)

Lidoplast 700mg - Lidocaine Patch

Midapic - Midazolam Injection IP 10ml

Midapic - Midazolam Injection IP 5ml

Nepar Forte - Acetaminophen and Codeine Phosphate Tablets

Rubuphine 10mg - Nalbuphine HCI Injection

Rubuphine 20mg - Nalbuphine HCI Injection

Rugalin 150mg - Pregabalin Capsules IP

Ruhusk - Ispaghula Husk ( Orange flavoured)

Rumorf - Morphine Sulphate Injection IP 10mg/ml

Rumorf -10 (Morphine Tablets IP 10mg)

Rumorf CR-20 ( Morphine Sulphate Controlled Release Tablets)

Rumorf SR - 10 ( Morphine Sulfate SR 10mg)

Rusan Pharma Ltd. has achieved two major regulatory milestones for its advanced manufacturing facility located in the Kandla Special Economic Zone (SEZ) Unit-II in Gujarat, India. The facility, which specializes in high-speed production of transdermal patches and oral films, has received Good Manufacturing Practice (GMP) certification from Australia’s Therapeutic Goods Administration (TGA) and a GMP extension from Brazil’s Health Regulatory Agency, ANVISA.

The TGA certification marks a pivotal step in Rusan Pharma’s expansion into the Australian market. Following a rigorous inspection, the facility was granted A1 GMP compliance, validating its capability to produce specialized drug delivery systems such as Buprenorphine, Nicotine Transdermal Patches, and Buprenorphine+Naloxone Sublingual Films. These products are designed to address critical medical needs in pain management and addiction treatment. This is the second time the TGA has approved the Kandla Unit-II faci...

Corporate+ Font Resize -Rusan Pharma achieves dual GMP milestones from TGA, Australia and ANVISA, for its manufacturing facilityOur Bureau, Mumbai
Friday, December 13, 2024, 16:45 Hrs  [IST]Rusan Pharma Ltd, a leading global pharmaceutical company specialising in addiction treatment and pain management, has announced two significant milestones for its state-of-the-art dedicated high-speed transdermal patch and oral film manufacturing facility, located in the Kandla Special Economic Zone (SEZ)-UNIT-II (Gujarat, India) (“KDL-2”). 

We are happy to announce the approval of our first finished dosage formulation (FDF) in Canada - RPC-Naltrexone Film-Coated Tablets (50 mg) (DIN: 02558343), through our subsidiary Rusan Pharma Canada Inc (RPCI).Rusan's Active Pharmaceutical Ingredient (API) and FDF manufacturing facilities are Health Canada GMP approved. With our integration to in-house manufacturing of the API - Naltrexone Hydrochloride, we plan to ensure that product has a robust supply chain and has a pan-Canadian reach.With this approval, we are excited to launch Rusan's global initiative and mission "FREEDOM FROM DEPENDENCE (PROJECT FREEDENCE)". Under this mission, we plan to become a global leader in addiction care (drugs, alcohol and tobacco), by introducing globally accepted treament standards such as Naltrexone Tablets, Buprenorphine+Naloxone Sublingual Tablets and films, Methadone Oral Solution, Nicotine gums, oral films and transdermal patches and other innovative delivery solutions.I am excited th...

RUSAN PHARMA PRIVATE LIMITED, an Indian pharmaceutical company specializing in addiction treatment and pain management, announced that its Active Pharmaceutical Ingredient (API) facility in Ankleshwar, Gujarat, received Good Manufacturing Practice (GMP) approval from the USFDA on May 29, 2024, following a rigorous inspection. This approval marks a significant milestone, enabling Rusan to expand into the US API market, particularly for niche APIs like Eflornithine and Nalmefene, while planning to add more APIs to its portfolio. Rusan Pharma’s Managing Director, Dr. Kunal Saxena, emphasized the company’s commitment to quality and global expansion. The USFDA approval complements Rusan's existing GMP certifications from Health Canada, the EU, and Brazil’s ANVISA, and aligns with the company’s vision to be a leader in addiction treatment and pain management.